VOSEVI FILM-COATED TABLETS 400MG/100MG/100MG [SIN15705P]

Product Info

VOSEVI FILM-COATED TABLETS 400MG/100MG/100MG

[SIN15705P]

4.1 Therapeutic indications

Vosevi is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults (see sections 4.2, 4.4 and 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.2 Posology and method of administration

Vosevi treatment should be initiated and monitored by a physician experienced in the management of patients with HCV infection.

Posology

The recommended dose of Vosevi is one tablet, taken orally, once daily with food (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

The recommended durations of treatment applicable to all HCV genotypes are shown in Table 1.

Missed dose
If a dose of Vosevi is missed and it is within 18 hours of the normal time, patients should be instructed to take the tablet as soon as possible and then patients should take the next dose at the usual time. If it is after 18 hours then patients should be instructed to wait and take the next dose of Vosevi at the usual time. Patients should be instructed not to take a double dose of Vosevi.

Patients should be instructed that if vomiting occurs within 4 hours of dosing, an additional tablet of Vosevi should be taken. If vomiting occurs more than 4 hours after dosing, no further dose of Vosevi is needed (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Elderly
No dose adjustment is warranted for elderly patients (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Renal impairment
No dose adjustment of Vosevi is required for patients with mild or moderate renal impairment. Safety data are limited in patients with severe renal impairment (estimated Glomerular Filtration Rate [eGFR] < 30 mL/min/1.73 m²) and end-stage renal disease (ESRD) requiring haemodialysis. Vosevi has not been studied in patients with ESRD requiring dialysis. Vosevi can be used in these patients with no dose adjustment when no other relevant treatment options are available (see section 4.4, 4.8, 5.1 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic impairment
No dose adjustment of Vosevi is required for patients with mild hepatic impairment (Child-Pugh-Turcotte [CPT] Class A). Vosevi is not recommended in patients with moderate or severe hepatic impairment (CPT Class B or C) or those with any history of prior hepatic decompensation (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Paediatric population
The safety and efficacy of Vosevi in children and adolescents aged less than 18 years have not yet been established. No data are available.

Method of administration

For oral use.

Patients should be instructed to swallow the tablet whole with food (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Due to the bitter taste, it is recommended that the film-coated tablet is not chewed or crushed.

4.3 Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Concomitant use with medicinal products that are strong P-glycoprotein (P-gp) and/or strong cytochrome P450 (CYP) inducers (e.g. carbamazepine, phenobarbital, phenytoin, rifampicin, rifabutin and St. John’s wort) (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Concomitant use with rosuvastatin or dabigatran etexilate (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Concomitant use with ethinylestradiol-containing medicinal products such as combined oral contraceptives or contraceptive vaginal rings (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).